Nutritional Status and Enteral Absorption Capability After Brain Death

NCT ID: NCT00858390

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-12-31

Brief Summary

The investigators propose to assess 36 donors' nutritional status using accepted parameters (prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through 13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to determine if continuing or initiating enteral feeding and nutritional supplementation is effective in restoring or maintaining nutritional parameters.

Detailed Description

There are an estimated 98,000 people in need of organ transplants in the United States (OPTN). Only a fraction of the need is met with the organs that become available. Therefore interventions are needed to maximize the viability of available organs and improve donor organ procurement and successful transplantation.

Improving the nutritional status of potential donors after they are declared brain dead could favorably impact subsequent organ procurement. Improved nutrition may improve organ viability by reducing the negative effects of inflammatory cytokines and catecholamines, and through reducing translocation of bacteria or endotoxin from the intestine.

In our preliminary work the investigators show significantly elevated inflammatory cytokines (IL-6 and TNFalpha) in unfed donors and a correlation with improved graft survival in recipients with lower plasma concentrations of IL-6.

The investigators propose to assess 36 donors' nutritional status using accepted parameters (prealbumin, resting energy expenditure); to assess nutrient intestinal absorption through 13Curacil breath tests; and to evaluate serum concentrations of IL-6 and TNFalpha to determine if continuing or initiating enteral feeding and nutritional supplementation is effective in restoring or maintaining nutritional parameters. Additionally, half of the group will be randomized to receive a nutritional supplement via naso/oro-duodenal feeding tube with a commercially available formula containing omega-3 and omega-6 fatty acids, and antioxidants plus glutamine (Oxepa® plus Glutasolve). The intervention through its anti-inflammatory and antioxidant functions has the potential to improve organ function (e.g. improved myocardial function (Wischmeyer 2003), and improved oxygenation (Pacht 2003; Pontes-Arruda 2006; Singer 2006)). Through improved organ function and/or a suppression of inflammatory cytokine production (e.g., IL-6 and TNFalpha) more organs are expected to be appropriate for procurement/transplantation.

If enteral nutrition reduces the inflammatory response commonly documented after brain death and, in doing so, improves organ procurement, enteral feeding could be immediately employed toward improving donor care practices. Furthermore, reducing the level of inflammatory molecules in donor organs may reduce the risk of rejection.

Conditions

Brain Death

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 standard care

organ donors receiving standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

2 Enteral Feeding

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Group Type: EXPERIMENTAL

enteral feeding with Oxepa® and Glutasolve®

Intervention Type: DIETARY_SUPPLEMENT

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Interventions

enteral feeding with Oxepa® and Glutasolve®

enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Consented solid organ donor

2. Age >14, <65 years old

3. Donors may have received or are receiving parenteral or enteral nutrition

Exclusion Criteria

1. Known gastric or small bowel resections

2. Known malabsorptive disease of the gastrointestinal tract

3. Bariatric procedures, vagotomy or pyloroplasty

4. Known acute or chronic pancreatitis

5. Requiring an FiO2 > 60%

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

LifeGift

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Georgene Hergenroeder

Assistant Professor, Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgene Hergenroeder, MHA, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Hospital

Houston, Texas, United States

Countries

United States

References

Hergenroeder GW, Ward NH, Yu X, Opekun A, Moore AN, Kozinetz CA, Powner DJ. Randomized trial to evaluate nutritional status and absorption of enteral feeding after brain death. Prog Transplant. 2013 Dec;23(4):374-82. doi: 10.7182/pit2013996.

Reference Type: RESULT

PMID: 24311403 (View on PubMed)

Other Identifiers

R38OT10585

Identifier Type: -

Identifier Source: secondary_id

HSC-MS-08-0473

Identifier Type: -

Identifier Source: secondary_id

R38OT10585

Identifier Type: -

Identifier Source: org_study_id